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Braces get a Tune-Up: study tests best heel cushion for easier walking

NCT ID NCT04800484

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how changing the heel cushion on an ankle-foot brace (AFO) affects walking in people who use one daily. Forty adults with leg injuries or nerve problems will try four different heel wedges—tall or short, soft or firm—while walking at controlled speeds. Researchers will measure forces, motion, comfort, and pain to find which setup works best. The goal is to give clinicians evidence to better adjust braces for everyday walking.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ankle-foot orthosis (AFO) heel wedges of varying height and stiffness
What this could lead to
If successful, this study could help doctors and therapists fine-tune braces to improve walking comfort and function for people with leg injuries or nerve problems.
What could go wrong
This is a small, early-stage study with only 40 participants. It measures walking mechanics and comfort, not long-term health outcomes, so results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2019

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

GROUP 1 Patient Inclusion criteria * Ages: 18-70 * Daily AFO use to address unilateral, below knee functional deficits that result from limb injury or musculoskeletal disease (e.g. fracture, muscle and/or nerve injury, ankle arthritis) * Greater than 2 weeks using their current AFO * Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.) * Ability to walk at a slow to moderate pace * AFO fits into traditional footwear * Able to read and write in English and provide written informed consent GROUP 1 Patient Exclusion criteria * Pain \> 6/10 while walking during testing or an increase in pain during testing of \> 2/10. * Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity). * Disorder or disease that affects peripheral nerve function (e.g. diabetes, Charcot Marie Tooth). * Limited contralateral lower limb function due to injury or neurological/musculoskeletal disorder. * Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot. * Use of an AFO that crosses the knee (Knee brace) * Insufficient space in shoe to accommodate the tallest heel wedge and their AFO * Visual or hearing impairments that limit walking ability or could limit the ability to comply with instructions given during testing * Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study. * Body Mass index \> 40. GROUP 2 Patient Inclusion Criteria * Ages: 18-70 * Daily AFO use to address below knee functional deficits that result from disease involving the peripheral nervous system (e.g. Charcot Marie Tooth, Multiple Sclerosis, diabetes) * Greater than 2 weeks using their current AFO (unilateral or bilateral) * Ability to walk 50 feet without use of an assistive device (Cane, crutch, etc.) * AFO fits into traditional footwear * Ability to walk at a slow to moderate pace * Able to read and write in English and provide written informed consent GROUP 2 Patient Exclusion Criteria * Pain \> 6/10 while walking or an increase in pain during testing of \> 2/10 * Central Nervous System disorder or disease (e.g. Stroke, Cerebral Palsy, Spinal Cord Injury, or other conditions that result in lower limb spasticity) * Limited function due to limb injury (e.g. fracture, muscle and/or nerve injury) * Use of a hinged/articulating AFO (e.g. Plantar flexion stop, Dorsiflexion assist/stop, free motion), Charcot Restraint Orthotic Walker (CROW) boot, AFOs that restrict all motion in the ankle and foot. * Use of an AFO that crosses the knee (Knee brace) * Insufficient space in shoe to accommodate the tallest heel wedge and their AFO * Visual or hearing impairment that limit walking ability or limit the ability to comply with instructions given during testing * Pregnancy - Per participant self-report. Due the expected small number of pregnant individuals, and resulting inability to account for its effect on resulting outcomes participants will be withdrawn from the study * Body Mass index \> 40.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

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